Formulation Technician II
ThermoFisher Scientific
**Work Schedule**
Flex 12 hr shift/days
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, No contact lens allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Warehouse
**Job Description**
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
**Responsibilities**
+ To perform visual inspection of pharmaceutical products to ensure that only products meeting quality, safety, and regulatory requirements are released, byidentifyingand rejecting units with visual defectsin accordance withapproved procedures and GMP standards.
+ Perform manual and/or automated visual inspection of finished or in-process pharmaceutical products (e.g.vials, syringes, bottles)
+ Inspect for defects such as: Particulates (visible and non-visible), cracks, chips, leaks, cosmetic defects, fill volume abnormalities, labeling and container integrity issues
+ Accuraterecord inspection results in batch records, logbooks, or electronic systems.
+ Ensure data integrity by completing records legibly, contemporaneously, and accurately.
+ Support investigations by providinginspectiondata and observations whenrequired.
+ Perform basic inspection equipment checks and lineclearanceprior to use.
+ Maintain cleanliness and organization of inspectionarea.
+ Report equipment malfunctions or environmental issues promptly.
+ Responsible for packaging andtransfer ofthe final product to Freezer.
+ Alwayscomplete all the relevant training beforeperforming any task.
+ Strictly follow aseptic techniques and practices for aseptic operations.
+ Carry out the cleaning and upkeep of the production equipment and classified areas inmanufacturingarea.
+ Timely completion of relevant batchrecordand logbooks for the tasks performed and with adherence to GDP (Good Documentation Practice).
+ Transfer materials for manufacturinga batch.
+ Provide forthe loading/unloading of the loads/batch from the equipment during production activities.
+ Perform stock check of consumables and inform Manager/Lead technicianfor requiredmaterials.
+ Follow safety and quality compliance at all timesand communicate in a timely mannertothemanagerif any anomalies are observed.
+ Participate in EHS, Business Compliance,cGMPand all other compliance-related matters, where applicable.
+ Perform all tasks in accordance with the standard operating procedures andmaintain strict compliancetoGMP at all times.
+ Report all the quality issuesimmediatelytoManageror Lead technician.
+ Conduct in-process inspection and checks.
+ Any other duties as and when assigned by the Manager.
**Requirements**
+ Minimum “O” Level, NITEC/ITE education.
+ Prior experience in pharmaceutical manufacturing or visual inspection is an advantage.
+ Good visual acuity and color vision (must pass periodic eye tests).
+ Basic understanding of GMP and data integrity principles.
+ Ability to work independently and in a team.
+ Able to work as a team.
+ Willingness to perform repetitive tasks for extended periods.
+ Ability to sit or stand for prolonged periods.
+ Ability to perform repetitive visual tasks with sustained focus.
+ Willingness to work shifts, ifrequired.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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